510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Event Medical Ltd

Lake Forest, CA, US

EVENT MEDICAL, LTD. appears in FDA device records in Lake Forest, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Event Medical Ltd between 2002 and 2013. The busiest year on record is 2004, with 2. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Event Medical Ltd, by decision year
YearClearances
20021
20042
20051
20081
20121
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130178INSPIRATION VENTILATOR SYSTEM 5I/7ICBKSubstantially Equivalent
K113743EVOLUTION 3E VENTILATORCBKSubstantially Equivalent
K072590INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEMCBKSubstantially Equivalent
K051550INSPIRATION VENTILATOR SYSTEMCBKSubstantially Equivalent
K040220MEDICAL AIR COMPRESSORBTISubstantially Equivalent
K030341MODIFICATION TO INSPIRATION VENTILATOR SYSTEMCBKSubstantially Equivalent
K021112INSPIRATION VENTILATOR SYSTEMCBKSubstantially Equivalent

Registered establishments

FDA registered establishments for Event Medical Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30061359413006135941EVENT MEDICAL, LTD.60 Empire Dr, Lake Forest, CA 92630 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0230-2016Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.Class ITerminated
Z-0062-06INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=RussianFirm received reports of combustion within the blender system of the Inspiration Ventilator.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain